Multi-Piece Anchor Inserter

ABSTRACT

Various devices, systems, and methods are provided for securing soft tissue to bone. In one exemplary embodiment, a two-piece inserter tool is provided that includes a tip portion that is configured to be removably coupled to a handle portion. A distal portion of the tip portion can be configured to be coupled to a suture anchor, and the tip portion and the anchor can be passed through a continuous suture loop prior to mating the tip portion to the handle portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 13/728,181filed on Dec. 27, 2012, and entitled “Multi-Piece Anchor Inserter,”which is hereby incorporated by reference herein in its entirety.

FIELD

The present invention relates generally to devices, systems, and methodsfor securing soft tissue to bone using a multi-piece anchor inserter.

BACKGROUND

Soft tissues, such as ligaments, tendons, and muscles, are attached to alarge portion of the human skeleton. In particular, many ligaments andtendons are attached to the bones which form joints, such as shoulderand knee joints. A variety of injuries and conditions require attachmentor reattachment of soft tissue to bone. For example, when otherwisehealthy tissue has been torn away from a bone, surgery is often requiredto reattach the tissue to the bone to allow healing and naturalreattachment to occur.

A number of devices and methods have been developed to attach softtissue to bone. These include screws, staples, cement, suture anchors,and sutures alone. Some of the more successful methods involve use of asuture anchor to attach a suture to the bone, and tying the suture in amanner that holds the tissue in close proximity to the bone.

Proper attachment of soft tissue to bone requires that it be placed inthe anatomically correct position to promote optimal healing.Conventional methods for attaching soft tissue to bone have typicallyused anchors through which a suture can be pulled to draw a piece ofsoft tissue attached to the suture into proximity of a surface of thebone after the anchor is inserted in a predrilled bone cavity. Suchmethods then require a free end or ends of the suture to be tied off tohold the soft tissue in place. More recently, however, “knotless” sutureanchors have been utilized to eliminate the need to tie off the freeend(s) of the suture. Many such “knotless” suture anchor systems controltension on tissue by a depth to which the anchor is driven into bone.Other “knotless” suture anchor systems utilize a sleeve that receivesthe anchor for locking the suture. Suture anchor systems with slidingknots for repairing torn or damaged tissue have also been traditionallyutilized.

The soft tissue may be attached to the bone during open surgery, orduring closed (e.g., arthroscopic) surgical procedures. Closed surgicalprocedures can be preferred since they are less invasive and are lesslikely to cause patient trauma. In a closed surgical procedure, asurgeon performs diagnostic and therapeutic procedures at a surgicalsite through small incisions, called portals, using instrumentsspecially designed for this purpose. One problem encountered in the lessinvasive, closed surgical procedures is that the surgeon hassignificantly less room to perform the required manipulations at thesurgical site than in open surgery. Thus, devices and methods are neededwhich will allow a surgeon to effectively and easily attach soft tissueto bone in the small spaces provided by less invasive surgicalprocedures.

Accordingly, there remains a need for improved devices, systems, andmethods for securing soft tissue to bone.

SUMMARY

The present invention generally provides multi-piece anchor insertersand methods of use. In one aspect, a suture anchor system is providedthat includes an anchor having proximal and distal ends with an innerlumen extending from the proximal end through at least a portionthereof, and an inserter tool having a handle portion and a separate tipportion. The anchor is configured to be implanted in bone. The tipportion has a proximal end configured to removably mate to a distal endof the handle portion and has a distal end configured to extend into atleast a portion of the inner lumen in the anchor for removably matingthe anchor to the tip portion of the inserter tool.

The system can vary in any number of ways. For example, the proximal endof the tip portion and the distal end of the handle portion can includecomplementary male and female mating elements configured to mate the tipportion to the handle portion. In one embodiment, the proximal end ofthe tip portion and the distal end of the handle portion can includethreads formed thereon and configured to threadably mate to one another.In another embodiment, the proximal end of the tip portion and thedistal end of the handle portion can mate by a snap-fit engagement. Forexample, one of the tip and the handle portion can include a protrusionthat is configured to be received within a groove or recess in or on theother one of the tip and the handle portion to thereby mate the twocomponents. For another example, the tip portion can include a shoulderformed thereon that is configured to abut a proximal-most end of theanchor when the distal end of the tip portion is inserted into the innerlumen in the anchor.

In some embodiments, the system can include a first suture extendingthrough the inner lumen of the anchor and having a sliding knot formedthereon and positioned within the anchor. The first suture can have afree end extending from the anchor and a collapsible loop portionextending from the anchor. In an exemplary embodiment, the system canalso include a second suture in the form of a continuous loop. Thesecond suture can be slidably disposed on the collapsible loop portionof the first suture. The second suture can have a diameter that is in arange of about 5 mm to 40 mm. The anchor can include a suture-engagingmember extending across the inner lumen, and the first suture can extendaround the suture-engaging member. For another example, the anchor caninclude at least one suture-receiving groove formed in an externalsurface thereof and extending therealong such that, when the anchor isimplanted in the bone, a suture positioned within the at least onesuture-receiving groove can slide freely relative to the anchor.

In another embodiment, a suture anchor system is provided and includesan anchor having proximal and distal ends and being configured to beimplanted in bone, a first suture coupled to the anchor, a second suturein the form of a continuous suture loop slidably disposed on the firstsuture, and an inserter tool having a handle portion and a separate tipportion. The tip portion can have a proximal end configured to removablymate to a distal end of the handle portion, and a distal end configuredto removably mating the anchor to the tip portion of the inserter tool.When the tip portion and the anchor are mated, the tip portion and theanchor can be configured to be passed through the second suture.

In another aspect, a surgical method is provided for securing tissue tobone. In one embodiment, the method can include passing a suture anchor,with a distal tip portion of an inserter tool coupled thereto, throughthough a loop portion of at least one suture coupled to tissue, couplingthe distal tip portion of the inserter tool to a handle portion of theinserter tool and manipulating the handle portion with the distal tipportion and the suture anchor attached thereto to implant the sutureanchor in bone, and removing the proximal handle portion and the distaltip portion of the inserter tool from the suture anchor, leaving thesuture anchor implanted in the bone.

In other aspects, a method is provided that includes passing a firstsuture through tissue such that a collapsible loop portion of the firstsuture extends from a first side of the tissue and first and secondtrailing ends of the first suture extend from a second opposite side ofthe tissue, the first and second trailing ends of the first suture beingcoupled to a suture anchor, and the collapsible loop portion of thefirst suture having a second suture in the form of a continuous loopdisposed thereon. The method can further include passing the sutureanchor, with a distal tip portion of an inserter tool coupled thereto,through the continuous loop, tensioning the first suture to slide thecontinuous loop along the collapsible loop portion of the first suturetoward the tissue, and coupling the distal tip portion of the insertertool to a handle portion of the inserter tool. The method can alsoinclude manipulating the handle portion with the distal tip portion andthe suture anchor attached thereto to implant the suture anchor in bone,removing the proximal handle portion and the distal tip portion of theinserter tool from the suture anchor, leaving the suture anchorimplanted in the bone, and tensioning the first suture relative to thesuture anchor to thereby tension the collapsible loop portion of thefirst suture and to thereby tension the continuous loop relative to thetissue, thereby securing the tissue to the bone.

The method can vary in any number of ways. For example, tensioning thefirst suture to slide the continuous loop along the collapsible loopportion of the first suture toward the tissue can include pulling thesuture anchor with the first suture coupled thereto. In another example,coupling the distal tip portion to the handle portion of the insertertool can include coupling male and female mating elements on the distaltip portion and the handle portion of the inserter tool. In someembodiments, tensioning the first suture relative to the suture anchorcan cause a slip knot formed on the first suture and disposed within thesuture anchor to slide along the first suture to thereby tension thecollapsible loop portion of the first suture and to thereby tension andlock the continuous loop relative to the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of one embodiment of a suture anchor systemincluding a two-piece inserter tool, a suture anchor, and first andsecond sutures;

FIG. 2 is a perspective view of an embodiment of a tip portion of aninserter tool;

FIG. 3 is an end view of the tip portion of FIG. 2;

FIG. 4 is an end view of another embodiment of a tip portion of aninserter tool;

FIG. 5 is a side, partially transparent view of another embodiment of asuture anchor;

FIG. 6 is another side, partially transparent view of the anchor of FIG.5;

FIG. 7 is a perspective view of the anchor of FIG. 5;

FIG. 8 is a side cross-sectional, schematic view of the first and secondsutures of FIG. 1 passed through a tissue and coupled to the anchor ofFIG. 1 and the tip portion of the inserter tool of FIG. 1;

FIG. 9 is a side cross-sectional, schematic view showing the tip portionand the anchor of FIG. 6 about to be passed through a continuous loop ofthe second suture of FIG. 8;

FIG. 10 is a side cross-sectional, schematic view of the tip portion andthe anchor of FIG. 7 passed through the continuous loop of the secondsuture of FIG. 9;

FIG. 11 is a side cross-sectional, schematic view of the second sutureof FIG. 10 slid down the first suture to be positioned around thetissue;

FIG. 12 is a side cross-sectional, schematic view of the tip portion ofFIG. 10 coupled to a handle portion of the inserter tool of FIG. 1;

FIG. 13 is a side cross-sectional, schematic view of the tip portion andthe anchor of FIG. 12 positioned in a bone hole;

FIG. 14 is a side cross-sectional, schematic view of the anchor of FIG.13 with the entire inserter tool removed therefrom; and

FIG. 15 is a side cross-sectional, schematic view of the anchor of FIG.14 with the first and second sutures tightened and an excess of thefirst suture trimmed and removed.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices, systems, and methods disclosedherein. One or more examples of these embodiments are illustrated in theaccompanying drawings. Those skilled in the art will understand that thedevices, systems, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Various devices, systems, and methods are provided for securing softtissue to bone. In general, various multi-piece inserter tools andmethods of use are provided. In one exemplary embodiment, a two-pieceinserter tool (also referred to herein as an “inserter”) is providedhaving a tip portion configured to be removably and replaceably coupledto a handle portion of the inserter tool. The tip portion can have asize configured to allow the tip portion to be inserted into an innerlumen of a suture anchor (also referred to herein as an “anchor”). Theanchor can have, or can be configured to have, one or more suturescoupled thereto. For non-limiting example, the anchor can be configuredto be coupled to a first, adjustable suture and a second, continuousloop suture. The adjustable suture can include first and second trailingends and a collapsible loop, and the continuous loop suture can be acontinuous loop that is slidably disposed on the collapsible loop of thefirst suture. The tip portion of the inserter can have a size and shapethat allows it to be passed through the continuous loop alone, as wellas when the tip portion is coupled to the anchor. Because the handleportion can be coupled to the tip portion after the tip portion and theanchor have been passed through the continuous loop as a unit, thehandle portion does not need to have a size that allows it to be passedthrough the continuous loop and can therefore have a larger size thanthe tip portion. The inserter tool can thus have a relatively large,easy-to-hold proximal handle while also having a distal tip that cancouple to a suture anchor and pass through a relatively small sutureloop. In using the anchor, the adjustable suture including the first andsecond trailing ends and the collapsible loop, and the continuous loopto secure soft tissue to bone, the collapsible loop is coupled to thecontinuous loop rather than being directly coupled to the soft tissue.The collapsible loop will thus not slide along the tissue duringtensioning of the adjustable suture, e.g., as the collapsible loopcollapses, and thus does not inadvertently cut, or “cheese wire,” thesoft tissue. The continuous loop also will not slide along the softtissue when the soft tissue is pulled toward the bone.

FIG. 1 illustrates one exemplary embodiment of a suture anchor system 10configured to anchor soft tissue to bone. The system 10 can include aninserter tool 12 and a suture anchor 30. The inserter tool 12 can beconfigured to deliver the suture anchor 30 to bone. A first, adjustablesuture 40 can be configured to be slidably coupled to the anchor 30, anda second suture in the form of a continuous loop 50 can be configured tobe slidably coupled to the adjustable suture 40.

The inserter tool 12 can be a multi-piece tool including at least twodiscrete portions configured to be removably and replaceably attached toone another. As in the illustrated embodiment, the inserter tool 12 caninclude two pieces, namely a handle portion 14 and a tip portion 16. Asshown, the handle portion 14 can include an elongate shaft 18 having ahandle 20 formed on a proximal end of the shaft 18. The handle 20 canfacilitate grasping and manipulation of the tool 12. While in theillustrated embodiment, the inserter tool 12 includes two removably andreplaceably coupled portions, in other embodiments, an inserter tool caninclude three or more removably and replaceably coupled portions. By wayof non-limiting example, one or both of a tool's handle portion and tipportion can be multiple separable parts. For non-limiting example, aninserter's handle portion can include a handle and a separate shaft. Thehandle portion 14 can thus be chosen according to preferences of a user,e.g., left or right handed, small or large hands, different grippingfeatures, different shaft diameters for differently sized accessdevices, patient anatomies, etc. For another non-limiting example, aninserter tool can have a plurality of differently sized and shapeddistal tip portions that can allow the inserter to be used withdifferently sized anchors, and, as discussed below, differently sizedcontinuous suture loops.

A distal end of the shaft 18 can include a first mating element 22 thatcan be configured to be removably coupled, as shown by arrow A, to asecond mating element 24 formed on a proximal end of the tip portion 16.In the illustrated embodiment, the first and second mating elements 22,24 are complementary male and female mating elements, respectively. Themale and female mating elements 22, 24 can be configured to couple invarious ways, such as via a threaded connection, snap-fit connection,interference fit, etc., as will be appreciated by a person skilled inthe art. In another embodiment, a tip portion can have a male matingelement that can be configured to removably couple to a female matingelement on a handle portion.

The dimensions of the handle and tip portions 14, 16 of the insert 12can vary. For non-limiting example, the tip portion 16 can have a firstouter diameter D1, and the shaft 18 can have a second outer diameter D2.While the first outer diameter D1 of the tip portion 16 is shown asbeing substantially the same as the second outer diameter D2 of theshaft 18, the tip portion's outer diameter D1 can be less than orgreater than the shaft's outer diameter D2. In an exemplary embodiment,the tip portion's outer diameter D1 is equal to or less than the outerdiameter D2 of the shaft 18 because, as discussed more fully below, thetip portion 16 can be sized for passage through the continuous loop 50,whereas the shaft 18 and the handle 20 can be larger because they do notneed to be passed through the continuous loop 50. The tip portion 16 andthe handle portion 14 can each have any longitudinal length. As shown,the tip portion 16 can have a shorter longitudinal length than thehandle portion 14. In other embodiments, a tip portion can have alongitudinal length that is equal to or greater than a longitudinallength of a handle portion. The longitudinal length of the tip portion16 can be optimized so that, as discussed below, the tip portion 16 canbe long enough easy grasping thereof, but short enough to facilitatepassage of the tip portion 16 through the continuous loop 50. In anexemplary embodiment, the tip portion 16 can have a longitudinal lengthin a range of about 1 to 2 inches.

In certain embodiments, the tip portion 16 can include a reduceddiameter portion 26 that is configured to fit within an inner lumen 32of the anchor 30. A cross-sectional shape of the reduced diameterportion 26 can vary, but in an exemplary embodiment, the reduceddiameter portion 26 can have a shape that allows the reduced diameterportion 26 to engage the inner lumen 32 extending through at least aproximal portion of the anchor 30. The reduced diameter portion 26 canbe a male mating element configured to be received in a correspondingfemale element of the anchor 30, e.g., in the inner lumen 32. In theillustrated embodiment, the reduced diameter portion 26 has a generallycircular cross-sectional shape that complements the generally circularcross-sectional shape of the inner lumen 32 in the anchor 30. In anotherembodiment, an inner lumen of the anchor can have anothercross-sectional shape, such as a generally hexagonal cross-sectionalshape that can complement a generally hexagonal cross-sectional shape ofan inner lumen extending through at least a proximal portion of ananchor.

A longitudinal length of the reduced diameter portion 26 can vary, butin an exemplary embodiment, the reduced diameter portion 26 can have alongitudinal length that allows the reduced diameter portion 26 toextend through a substantial portion of the anchor's lumen 32. Fornon-limiting example, the longitudinal length of the reduced diameterportion 26 can allow the reduced diameter portion 26 to extend throughthe inner lumen 32 to a point just proximal of a suture-engaging member36 positioned in a distal portion of the anchor 30. The suture-engagingmember 36 is discussed further below. A person skilled in the art willappreciate that the reduced diameter portion 26 can have a variety ofshapes, sizes, and configurations so that the reduced diameter portion26 can be configured to be disposed within anchors of various shapes,sizes, and configurations.

The tip portion 16 can be configured to receive multiple strands of theadjustable suture 40. The tip portion 16 can be configured to allow theadjustable suture 40 to be coupled to the anchor 30, and to allowmultiple strands of the adjustable suture 40 to be passed through thetip portion 16 so as to extend proximally beyond the anchor 30 and thetip portion 16. For non-limiting example, the tip portion 16 can haveone or more inner lumens extending therethrough and/or one or moresuture-seating features, e.g., recesses, grooves, etc., formed in anexternal surface thereof configured to receive one or more suturestherein. The one or more suture-seating features can allow suture(s)seated therein to be seated flush or sub-flush with the external surfaceof the tip portion 16. This seating can facilitate free slidablemovement of the suture(s) relative to the top portion 16.

FIGS. 2-3 illustrate an embodiment of a tip portion 216 that includes asuture-seating groove 228. While a tip portion can have any number ofsuture grooves, the illustrated tip portion 216 has a single groove 228that extends longitudinally from a distal end of the tip portion 216 andterminates distal of a proximal end of the tip portion 216. In otherembodiments, a suture receiving groove can extend another distance alongan axial length of a tip portion, including along an entire longitudinallength of the tip portion. A proximal portion of the groove 228 caninclude an angled portion 250, which can provide a smooth transitionbetween an external surface of the tip portion 216 and the groove 228.The angled portion 250 can thus help reduce wear on a suture seated inthe groove 228. The groove 228 can include a reduced-area portion 252 inwhich an open width of the groove 228 is decreased. This decreased openwidth can help prevent anchor breakage when impacted into bone, and itcan also help aid in retaining a suture within the groove 228. In otherembodiments, the groove can be entirely enclosed and in the form of atunnel.

A tip portion having multiple suture seating features can be sized toseat one or more suture strands. Having multiple suture seating featurescan facilitate an ordered arrangement of multiple suture strands. FIG. 4illustrates an exemplary embodiment of a tip portion 416 having multiplesuture seating features in the form of grooves 428A, 428B. The grooves428A, 428B can have any size, configuration, and shape. Although onlytwo grooves 428A, 428B are shown, as mentioned above, a tip portion caninclude more than two suture seating features, In the illustratedembodiment, the grooves 428A, 428B have a substantially triangular crosssectional shape, are substantially the same size, and are on opposedsides of the tip portion 416. The substantially triangular shape canfacilitate retention of one or more sutures in the grooves 428A, 428B,e.g., in a pointed portion of the grooves 428A, 428B toward a radialcenter of the tip portion 416. In some embodiments, the suture seatingfeatures can have different sizes for, e.g., retention of differentnumbers or sizes of strands of suture; the suture seating features canbe at a position other than on opposed sides of a tip portion; e.g.,spaced ninety degrees apart; and the suture seating features can have arounded cross sectional shape, etc.

Similar to the tip portion 16 of FIG. 1, the tip portion 216 shown inFIG. 2 can include a mating element 224 configured to removably couplethe tip portion 216 to the handle portion 16 and/or one or more otherhandle portions. The tip portion 216 can include at a distal end thereofa reduced diameter portion 226 configured to be inserted into an innerlumen of the anchor. A shoulder 254 at a proximal end of the reduceddiameter portion 226 can be configured to abut a proximal end of ananchor when the reduced diameter portion 226 is inserted into theanchor's inner lumen. The shoulder 254 can transfer a driving force froma proximal portion of an inserter tool to the anchor, and can prevent adistal end of the reduced diameter portion 226 from coming into contactwith a suture-engaging member in the anchor and/or sutures coupled tothe anchor to thereby prevent the reduced diameter portion 226 fromdamaging sutures disposed around the suture-engaging member, orotherwise damaging the sutures. The shoulder 254 can also provide anindication to a user that the tip portion 216 is fully inserted in ananchor because the shoulder 254 abutting the proximal end of the anchorcan be palpably felt when the reduced diameter portion 226 of the tipportion 216 is advanced distally into the anchor's inner lumen.

Referring again to FIG. 1, the anchor 30 can have a variety of shapes,sizes, and configurations. Various exemplary embodiments of sutureanchors that can be used with the inserters disclosed herein aredescribed in further detail in U.S. Pat. No. 8,114,128 entitled“Cannulated Suture Anchor” issued Feb. 14, 2012, U.S. Patent PublicationNo. 2009/0076544 entitled “Dual Thread Cannulated Suture Anchor” filedSep. 14, 2007, U.S. Patent Application No. 2012/0165864 entitled“Adjustable Anchor Systems and Methods” filed Dec. 23, 2010, and U.S.patent application Ser. No. 13/331,867 entitled “Knotless InstabilityAnchor” filed Dec. 20, 2011, which are hereby incorporated by referencein their entireties. Non-limiting examples of suture anchors that can beused with the inserters disclosed herein include GRYPHON™ Anchors andHEALIX™ Anchors available from Depuy Mitek, Inc. of Raynham, Mass. Thesuture anchors discussed herein can have any of a variety of sizes,depending on patient anatomy, procedure type, suture size, and/orvarious other parameters, which will be appreciated by a person skilledin the art. In some embodiments, the suture anchors discussed can have asize in a range between about 1 mm to 12 mm in diameter and in a rangebetween about 2 mm to 24 mm in length.

In the illustrated embodiment, the anchor 30 includes an elongate memberhaving proximal and distal ends with the inner lumen 32 extendingbetween the proximal and distal ends of the anchor 30. As discussedabove, the inner lumen 32 can be configured to receive at least aportion of the tip portion 16 therein, e.g., the reduced diameterportion 26 of the tip portion 16. The lumen 32 can extend through anentire length of the anchor 30 from a proximal end of the anchor 30 tothe distal end of the anchor 30, as in the illustrated embodiment, orthe inner lumen 32 can extend from the proximal end of the anchor 30 toa point proximal of the distal end of the anchor 30.

As mentioned above, the anchor 30 can include the suture-engaging member36 formed therein. The suture-engaging member 36 can have a variety ofsizes, shapes, and configurations. An angular orientation of thesuture-engaging member 36 relative to a longitudinal axis of the innerlumen 32 can vary, but in an exemplary embodiment the suture-engagingmember 36 extends substantially perpendicular to a longitudinal axis ofthe inner lumen 32. A location of the suture-engaging member 36 can alsovary, but in an exemplary embodiment the suture-engaging member 36 ispositioned at or adjacent to a distal end of the suture anchor 30. Inthe embodiment shown in FIG. 1, the suture-engaging member 36 is locatedjust proximal to a distal-most end of the suture anchor 30 so as to forma suture-seating groove 41 in the distal-most end of the suture anchor30. This recessed configuration of the suture-engaging member 36 canallow suture(s) disposed around the suture-engaging member 36 to sitflush or sub-flush with the distal end of the suture anchor 30, whichcan help prevent the suture(s) from interfering with insertion of thesuture anchor 300 into bone. A knot 42 formed in the adjustable suture40 is shown in FIG. 1 seated in the suture-seating groove 41. A personskilled in the art will appreciate that the suture-engaging member 36can be integrally formed with the suture anchor 300, e.g., the sutureanchor 30 and suture-engaging member 36 can be molded as a single unitor formed from a single piece of material, or the suture-engaging member36 can be an independent element fixedly or removably mated to thesuture anchor 30.

The suture-engaging member 36 can be configured to engage one or moresutures that extend through the inner lumen 32 of the suture anchor 30.As in the illustrated embodiment, the suture-engaging member 36 can beconfigured to prevent the knot 42 of the adjustable suture 40 frommoving in a proximal direction when proximal tension is applied to theadjustable suture 40, as discussed further below. The distal end of theanchor 30 can include a pointed or rounded tip 39, which can facilitateinsertion of the anchor 30 into bone.

The anchor 30 can include at least one bone-engaging surface feature 38configured to engage bone. The at least one bone-engaging surfacefeature 38 can have a variety of configurations, shapes, and sizes. Theat least one bone-engaging surface feature 38 can be formed on at leasta portion of an external surface of the anchor 30, e.g., in a proximalportion of the anchor 30. A distal portion of the anchor 30 can be freeof the at least one bone-engaging surface feature 38, which canfacilitate insertion of the anchor 30 into bone. In another embodiment,at least one bone-engaging surface feature can be formed along an entirelength or along discrete portions of an anchor. While variousbone-engaging surface features can be used, such as teeth, ridges,flanges, ribs, barbs, protrusions, etc., as in the illustrated exemplaryembodiment, the anchor 30 can include at least one bone-engaging surfacefeature 38 in the form of one or more ridges. In the illustratedembodiment, the anchor 30 includes a plurality of ridges spaced axiallyalong a length of the proximal portion of the anchor 30.

An anchor can include one or more suture-receiving grooves (not shown)formed on an external surface of the anchor, similar to the grooves428A, 428B in the tip portion 416 of FIG. 4. The groove(s) can extendtherealong the anchor such that, when the suture anchor is implanted inbone, suture(s) positioned within the groove(s) can slide freelyrelative to the anchor. The groove(s) can extend along any portion ofthe anchor, but in an exemplary embodiment, the groove(s) can extend atleast from a proximal end of the anchor to a suture-engaging member in adistal portion of the anchor, which can allow suture(s) extending aroundthe suture-engaging member to be seated in the groove(s).

FIGS. 5-7 illustrate another embodiment of an anchor 300. The anchor 300in the illustrated embodiment includes a suture-engaging member 336 inthe form of a post that extends transversely across an inner lumen 332of the anchor 300 and between opposed inner sidewalls of the sutureanchor 300. An angular orientation of the suture-engaging member 336relative to a longitudinal axis E of the inner lumen 332 can vary, asmentioned above regarding the suture-engaging member 36 of FIG. 1. Theanchor 300 can include a plurality of bone-engaging surface features338, which in the illustrated embodiment are in the form of a pluralityof circumferential ridges spaced axially along a proximal portion of theanchor 300 that terminate at a location proximal to the suture-engagingmember 336. The anchor 300 can also include one or more bone-penetratingfeatures 339 a, 339 b at the distal-most end thereof that are configuredto facilitate insertion of the anchor 300 into bone. Thebone-penetrating features 339 a, 339 b in the illustrated embodimentinclude a chamfered edge and pointed tip. The space between the opposedbone-penetrating features 339 a, 339 b can define a pocket for seating aknot in a suture, as will be discussed below.

The suture anchors discussed herein can be formed from any one or moreof a variety of materials. In some embodiments, the suture anchors canbe formed from a biocompatible, bioabsorbable material which can reduceimmunological problems associated with having a foreign substance withinthe body over a prolonged period of time. Exemplary materials from whichthe suture anchors discussed herein can be formed include bioabsorbableelastomers, copolymer combinations such as polylactic acid-polyglycolicacid (PLA-PGA), and bioabsorbable polymers such as aliphatic polyesters,poly(amino acids), copoly(ether-esters), polyalkylenes oxalates,polyamides, tyrosine derived polycarbonates, poly(iminocarbonates),polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesterscontaining amine groups, poly(anhydrides), polyphosphazenes,biomolecules (e.g., biopolymers such as collagen, elastin, bioabsorbablestarches, etc.) and blends thereof. In some embodiments, the sutureanchors can be formed from polylactic acid, or a composite blend oftricalcium phosphate and polylactic acid. The suture anchors discussedherein can also be formed from non-absorbable materials, such aspolyether ether ketone (PEEK), polysulfone, or metals such as titanium.A suture-engaging element of the suture anchor can also be formed fromany one or more of the materials listed above, including titanium.

Referring again to FIG. 1, the anchor 30 can be configured to couple toone or more sutures, e.g., the adjustable suture 40 and the continuousloop 50. While only two sutures 40, 50 are illustrated in FIG. 1, anynumber of sutures can be coupled to the anchor 30 and used to securesoft tissue to bone. The adjustable suture 40 and the continuous loop 50can be made from the same or different material and can have the same ordifferent diameters. For non-limiting example, one of the sutures 40, 50can be formed from a suture having a lower abrasive property at itssurface. The lower abrasive property can be achieved by a largerdiameter, a softer composition, a softer braid, plait or strand pattern,or a combination of such characteristics. The continuous loop 50 can beformed from a suture that is tied with a fixed knot to form thecontinuous loop, or alternatively, the continuous loop 50 can be moldedor otherwise formed as a ring of material. The diameter of thecontinuous loop 50 can vary depending on the surgical procedure and theanatomy of the patient. The diameter of the continuous loop 50 can besized so that, as discussed more fully below, the continuous loop 50 issmall enough to sufficiently engage tissue to be approximated, and notbe pulled into the inner lumen 32 of the anchor 30, but large enoughthat the anchor 30 and the tip portion 16 can be passed through thecontinuous loop 50 and large enough to substantially wrap around thesoft tissue (see FIG. 11). In some embodiments, the diameter of thecontinuous loop 50 can be in a range of about 2 mm to 50 mm, and inother embodiments be less than 25 mm, 15 mm, 10 mm, or 5 mm, etc. Theadjustable suture 40 and the continuous loop 50 can be coupled to theanchor 30 in a variety of ways, e.g., by hand, by using a suturethreading device, etc. In some embodiments, the adjustable suture 40 canbe pre-coupled to the continuous loop 50 and can be pre-loaded withinthe inner lumen 32 of the anchor 30, e.g., packaged as a pre-loadedunit, which can speed usage of the anchor 30 in a surgical procedure.

As shown in FIG. 1, the adjustable suture 40 can be in the form of asingle elongate strand that is folded, e.g., folded in half, to form acollapsible loop 46 having first and second trailing ends 48 a, 48 b.One of the first and second trailing ends 48 a, 48 b, e.g., the secondtrailing end 48 b, can be tied into a slip knot 42 slidably disposedalong the other trailing end, e.g., the first trailing end 48 a, suchthat the first trailing end 48 a extends from the knot 42. As a result,a portion of the collapsible loop 46 extending from one side of the knot42 is referred to herein as a collapsible loop portion, and a portionextending from the other side of the knot 42 is referred to herein as afirst free end. The continuous loop 50 can be a continuous, closed loopslidably disposed on the collapsible loop 46 of the adjustable suture40. The knot 42 can be any sliding and/or lockable knot, as will beappreciated by a person skilled in the art, such as a Tennessee Sliderknot. Various embodiments of knots are described further in previouslymentioned U.S. Patent Application No. 2012/0165864. While the adjustablesuture 40 in the illustrated embodiment includes only a single knot 42,the adjustable suture 40 can include any number of knots as appropriatefor a certain procedure or as preferred by a surgeon. While theadjustable suture 40 in the illustrated embodiment only has one free endand the collapsible loop portion via a single knot 42, any otherconfiguration where tension on one or more free ends of a suture resultsin slidably pulling a continuous loop towards a suture anchor can beused. For non-limiting example, a suture anchor can be configured toallow one or more sutures to be so configured without the need for asliding knot. In one embodiment, a suture anchor can have a lockingelement or feature that can be configured to lock a suture relative tothe anchor without the need for a knot. In other aspects, trailing endsof a suture extending from a suture anchor can be tied off.

A suture anchor kit can be provided including one or more anchors, twoor more sutures, and one or more inserter tools, including any number ofhandle portions and/or tip portions, each configured to removably andreplaceably mate with at least one of the anchors. Alternatively, thekit can include one or more anchors and one or more inserter tool tipportions, and the sutures can be separately obtained. In an exemplaryembodiment, each of the tip portions in a kit can have a different size,e.g., a different outer diameter, and can be configured to removablycouple to an inserter handle portion. The inserter handle portion can beincluded in the kit and can be configured to removably and replaceablymate with each of the tip portions in the kit. Each of the sutures canhave different material properties or thicknesses. At least one of thesutures in the kit can be in the form of a continuous loop. Thecontinuous loop(s) can have different circumferences. Each of theanchors can have different sizes and/or different configurations forengaging bone. In this way, the anchors, sutures, and tip portionshaving the most appropriate sizes, shapes, and configurations can beselected for use in a particular surgical procedure with a particularpatient, which can help a single kit accommodate different situations,such as different surgical procedures, different patient anatomies, andvarious tissue sizes. As discussed below, the suture(s) can bepre-loaded in the anchors(s), or the suture(s) can be loaded duringsurgery.

FIGS. 8-15 illustrate an exemplary embodiment of a surgical procedurefor soft tissue repair. Although the procedure is illustrated withrespect to the inserter tool 12 and the anchor 30 of FIG. 1, any of theanchors and inserter tools discussed herein can be similarly used. Inthe illustrated embodiment, the soft tissue repair is performed via aminimally invasive procedure, such as an arthroscopic procedure whereone or more access devices are used to form working channels fromoutside of a patient's body to a surgical site. For ease and clarity ofillustration, the one or more access devices are not illustrated inFIGS. 8-15. In addition, the illustrated embodiment is not limited tominimally invasive procedures and can, for non-limiting example, beperformed in open surgery or in robot-assisted surgery. Also, althoughthe procedure is illustrated with respect to a soft tissue repair, anyof the suture anchors and inserter tools discussed herein can be used tosurgically repair various problems.

As shown in FIG. 8, an incision in skin 64 can be formed in proximity toan area of a bone 60 of a patient to which a piece of soft tissue 62 isto be approximated. The adjustable suture 40 and the continuous loop 50can then be passed through the incision, e.g., using aminimally-invasive surgical access device (not shown). The adjustablesuture 40 and the continuous loop 50 can be passed through the softtissue 62 in a direction of arrow B, e.g., using a needle (not shown),so that the continuous loop 50 and the collapsible loop portion 46 ofthe adjustable suture 40 can extend from one side of the tissue 62, andthe first and second trailing ends 48 a, 48 b of the adjustable suture40 can extend from another, opposite side of the tissue 62. Thedirection of the arrow B is an illustrative example only, and dependingon an orientation of the tissue 62, other patient anatomy, and/or onsurgeon preference, the adjustable suture 40 and the continuous loop 50can be passed in another direction. After passing the adjustable suture40 and the continuous loop 50 through the tissue 62, the continuous loop50 with the collapsible loop 46 coupled thereto can be pulled backthrough the access device and the incision so that the continuous loop50 is positioned outside the patient's body, as illustrated in FIG. 8.

The anchor 30 and the tip portion 16 can be coupled to the adjustablesuture 40 before the adjustable suture 40 and the continuous loop 50 arepassed through the tissue 62, as shown in FIG. 8. Alternatively, theanchor 30 and the tip portion 16 can be coupled to the adjustable suture40 after the adjustable suture 40 and the continuous loop 50 have beenpassed through the tissue 62.

Depending on a surgical procedure being performed, a circumference ofthe continuous loop 50 can be relatively small, e.g., in a range ofabout 2 mm to 50 mm. Passing the anchor 30 through the continuous loop50 can therefore be challenging. To make passing the anchor 30 throughthe continuous loop 50 easier, the tip portion 16 of the inserter tool12 can be coupled to the anchor 30 prior to the anchor 30 being passedthrough the continuous loop 50 to allow the anchor 30 and the tipportion 16 to be advanced through the continuous loop 50 as a singleunit. In the illustrated embodiment, the tip portion 16 is coupled tothe anchor 30 before the anchor 30 is passed through the continuous loop50. Further, a typical suture anchor is a relatively small device, e.g.,in a range of about 1 mm to 12 mm in diameter and in a range of about 2mm to 24 mm in length, which can make the anchor difficult to grasp. Forexample, it can be difficult to mount the anchor on the tip whilemanaging the sutures coupled to the anchor. If the sutures get pinchedor twisted around each other during assembly, then the sutures will notslide smoothly and the sliding knot may not work properly. Therefore, itis preferred to have the suture, anchor, and tip assembled duringmanufacture. As discussed above, in the illustrated embodiment, the tipportion 16 can have a length in a range of about 1 to 2 inches. Thus,the relatively large tip portion 16 can allow the relatively smallanchor 30 to be more easily grasped, e.g., by hand, by tool, by roboticarm, etc., making passage of the anchor 30, and any sutures coupledthereto, through the continuous loop 50 easier.

Because the tip portion 16 can be separable from the handle portion 14,an entirety of the inserter tool 12 need not be advanced through thecontinuous loop 50. Instead, only a relatively small portion of theinserter tool 12 need be advanced through the continuous loop 50, namelythe tip portion 16, to couple the anchor 30 to a driver device. Theanchor 30 can thus be passed through the continuous loop 50 withouthaving to spend time feeding a relatively lengthy driver device throughthe continuous loop 50, which could risk fraying or otherwise damagingthe suture and having to begin the suture coupling process all overagain. The handle portion 14 can be configured to couple to the tipportion 16 after the tip portion 16 and the anchor 30 have been passedthrough the continuous loop 50, thereby avoiding passage of therelatively lengthy handle portion 14 through the continuous loop 50while facilitating handling of the anchor 30 from outside the patient'sbody. Having two or more inserter tool portions can therefore allow theinserter 12 to have a first, relatively narrow tip portion 16 of, e.g.,the tip portion 16 having the first diameter D1, and a second, largerportion, e.g., the handle portion 14 having the second diameter D2,which can be more easily handled by hand and/or instrument than thesmaller tip portion 16.

As shown in FIG. 9, after the adjustable suture 40 and the continuousloop 50 have been passed through the tissue 62 and the continuous loop50 is positioned outside of the patient's body, the tip portion 16 andthe anchor 30 can be passed through the continuous loop 50, as shown byarrow C. The direction of the arrow C is an illustrative example only,and depending on an orientation of the tip 16, the anchor 30, thecontinuous loop 50, etc. and/or on surgeon preference, the tip 16 andthe anchor 30 can be passed in another direction through the continuousloop 50. As shown, the proximal end of the tip portion 16 can be passedthrough the continuous loop 50 first. Alternatively, the distal end ofthe anchor 30 can be passed through the continuous loop 50 first.Passing the proximal end of the tip portion 16, and hence the proximalend of the anchor 30, through the continuous loop 50 first can helpposition the distal end of the anchor 30 in a more natural position foradvancement through the skin 64 and into the bone 60 underlying the skin64.

As shown in FIG. 10, with the anchor 30 and the tip portion 16positioned outside the patient's body and passed through the continuousloop 50 such that the continuous loop 50 is slidably disposed along thecollapsible loop 46 of the adjustable suture 40. Proximal tension can beapplied to the adjustable suture 40, thereby sliding or “zip lining” thecontinuous loop 50 along the collapsible loop 46, e.g., along thecollapsible loop portion 48 b. This sliding or “zip lining” can pull thecontinuous loop 50 through the access device (not shown), into thepatient's body through the skin 64, and around the tissue 62, as shownin FIG. 11. A length of the collapsible loop portion of the adjustablesuture 40 can be adjusted by applying proximal tension to the free end48 a of the adjustable suture 40, which can help eliminate anyunnecessary excess length or slack in the collapsible loop 46 of theadjustable suture 40.

As shown in FIG. 12, with the continuous loop 50 extending through thetissue 62 and being slidably disposed on the collapsible loop 46, thehandle portion 14 of the inserter tool 12 can be coupled to the tipportion 16, e.g., by mating the first and second complementary male andfemale mating elements 22, 24. The handle and tip portions 14, 16 can,however, be mated together prior to tensioning the adjustable loop 46.As shown in FIG. 12, if not previously formed, a hole 66 can be formedin the bone 60, e.g., drilled in the bone 60. Alternatively, the sutureanchor 30 can be self-drilled or self-tapped directly into the bone 60such that the hole 66 is not pre-formed.

The inserter tool 12 can be used to advance the anchor 30 into the bone60, as shown in FIG. 13. During insertion of the anchor 30 into the bone60, the free end 48 a of the adjustable suture 40 can be positionedexternal to the inserter tool 12 and proximal of the incision. In someembodiments, a handle portion of an inserter tool can be cannulated suchthat a free end of a first suture can extend through the handle portionand out a proximal end thereof.

As illustrated in FIG. 14, a proximal tension can be applied to the freeend 48 of the adjustable suture 40, thereby collapsing the collapsibleloop 46 by sliding the knot 42 therealong. This can be done eitherbefore or after removing the inserter, but preferably after removing theinserter. As the collapsible loop 46 collapses, the collapsible loop 46slides along the continuous loop 50 and applies a pulling force to thecontinuous loop 50, which pulls the continuous loop 50 and the tissue 62towards the bone 60, as shown in FIG. 15. Because the collapsible loop46 external to the tissue 62 and sliding relative to the continuous loop50 extending through the tissue 62, which merely tightens, positioningthe tissue 62 against the bone 60 can involve a minimal amount of suturesliding through the tissue 62, thereby reducing chances of tissuedamage, e.g., by reducing chances of cheese-wiring through the tissue62. In the illustrated embodiment, the diameter of the continuous loop50 is sized for use with multiple tissue thicknesses. For example, thecontinuous loop 50 can have a diameter that allows the loop to extendinto the inner lumen 32 of the anchor 30, thus ensuring that the loopwill retain any tissue thickness and essentially providing aone-size-fits-all suture anchor system. While the loop 50 can extendinto the inner lumen 32 of the anchor 30, the loop 50 preferably doesnot extend all the way to the suture-engaging member 36. The adjustablesuture 40 can be secured if, for example, the knot 42 and/or thesuture-engaging member 36 does not automatically lock the adjustablesuture 40 in place.

After advancing the anchor 30 into the bone 60 and tensioning theadjustable suture 40 to secure the tissue 62 to the bone 60, theinserter tool 12 can be removed from the anchor 30 as a single unit,e.g., with the handle and tip portions 14, 16 attached together.Removing the tool 12 as a single unit can facilitate removal of therelatively small tip 16 from the anchor 30 positioned in the bone 60.Any excess amount of the adjustable suture 40 can be trimmed andremoved. In an exemplary embodiment, the inserter is removed beforetensioning the tissue. This can provide the surgeon with an unobstructedview and freedom from the inserter.

In the present disclosure, like-numbered components of the embodimentsgenerally have similar features, and thus within a particular embodimenteach feature of each like-numbered component is not necessarily fullyelaborated upon. Sizes and shapes of the devices described herein, andthe components thereof, can depend at least on anatomy of a subject inwhich the devices will be used, size and shape of components (e.g.,sutures) with which the devices will be used, and the methods andprocedures in which the devices will be used. The figures providedherein are not necessarily to scale. Although the devices and methodsdisclosed herein are generally directed to surgical techniques, they canalso be used in applications outside of the surgical field.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Although the invention has been described by reference to specificembodiments, it should be understood that numerous changes may be madewithin the spirit and scope of the inventive concepts described.Accordingly, it is intended that the invention not be limited to thedescribed embodiments, but that it have the full scope defined by thelanguage of the following claims.

What is claimed is:
 1. A method for securing tissue to bone, comprising:passing a suture anchor, with a distal tip portion of an inserter toolcoupled thereto, through though a loop portion of at least one suturecoupled to tissue; coupling the distal tip portion of the inserter toolto a handle portion of the inserter tool and manipulating the handleportion with the distal tip portion and the suture anchor attachedthereto to implant the suture anchor in bone; and removing the proximalhandle portion and the distal tip portion of the inserter tool from thesuture anchor, leaving the suture anchor implanted in the bone.
 2. Themethod of claim 1, further comprising, after implanting the sutureanchor in bone, tensioning the at least one suture to anchor the tissueto the bone.
 3. The method of claim 1, wherein coupling the distal tipportion to the handle portion of the inserter tool comprises couplingmale and female mating elements on the distal tip portion and the handleportion of the inserter tool.
 4. The method of claim 1, wherein the atleast one suture comprises a first suture passed through tissue suchthat a collapsible loop of the first suture extends from a first side ofthe tissue and first and second trailing ends of the first suture extendfrom a second opposite side of the tissue, the first and second trailingends of the first suture being coupled to a suture anchor.
 5. The methodof claim 4, wherein the collapsible loop of the first suture has asecond suture in the form of a continuous loop disposed thereon, andwherein the suture anchor, with the distal tip portion of the insertertool coupled thereto, is passed through the continuous loop.
 6. Themethod of claim 5, further comprising, after passing the suture anchorand distal tip portion through the continuous loop, tensioning the firstsuture to slide the continuous loop along the collapsible loop of thefirst suture toward the tissue.
 7. The method of claim 6, whereintensioning the first suture to slide the continuous loop along thecollapsible loop of the first suture toward the tissue comprises pullingthe suture anchor with the first suture coupled thereto.
 8. The methodof claim 5, further comprising, after removing the proximal handleportion and the distal tip portion of the inserter tool from the anchor,tensioning the first suture relative to the suture anchor to therebytension the collapsible loop portion of the first suture and to therebytension the continuous loop relative to the tissue, thereby securing thetissue to the bone.
 9. The method of claim 8, wherein tensioning thefirst suture relative to the suture anchor causes a slip knot formed onthe first suture and disposed within the suture anchor to slide alongthe first suture to thereby tension the collapsible loop of the firstsuture and to thereby tension and lock the continuous loop relative tothe tissue.